Percutaneous annuloplasty system with anterior-posterior adjustment

ABSTRACT

Apparatus, systems, and methods are provided for repairing heart valves through percutaneous transcatheter delivery and fixation of annuloplasty rings to heart valves. An annuloplasty ring includes an outer hollow body member including a plurality of regions. Adjacent regions cooperate with one another to change the body member from an elongate insertion geometry to an annular operable geometry. Adjacent regions are coupled by a biasing element or a stepped connector to allow expansion to an expanded state and contraction to a contracted state in the annular operable geometry. The annuloplasty ring also includes an internal anchor member located at least partially within the body member and having a plurality of anchors configured to attach the annuloplasty ring to tissue of a heart valve annulus. An angled ring closure lock allows coupling of the ends of an annuloplasty ring at an apex of a D-shape annular operable geometry.

RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. § 119(e) of U.S.Provisional Patent Application No. 61/604,856, filed Feb. 29, 2012, andtitled “PERCUTANEOUS ANNULOPLASTY SYSTEM WITH ANTERIOR POSTERIORADJUSTMENT,” and of U.S. Provisional Patent Application No. 61/734,904,filed Dec. 7, 2012, and titled “ROTATIONAL BARBS,” each of which ishereby incorporated herein by reference in its entirety.

TECHNICAL FIELD

The present disclosure relates to treating and repairing heart valves,and specifically to apparatus, systems, and methods for percutaneoustranscatheter repair of heart valves. Disclosed embodiments includeadjustable annuloplasty rings that are configured to be deliveredthrough a catheter using, for example, a trans-septal approach, aretrograde approach, or a trans-apical approach.

BACKGROUND INFORMATION

Heart valve defects, such as regurgitation, may be caused by arelaxation of the tissue surrounding a heart valve (e.g., the mitralvalve or tricuspid valve). This causes the valve opening to enlarge,which prevents the valve from sealing properly. Such heart conditionsare commonly treated by a procedure during which an annuloplasty ring isfixed or secured to the annulus of the valve. Cinching or securing thetissue of the annulus to the annuloplasty ring can restore the valveopening to its approximate original size and operating efficiency.

Typically, annuloplasty rings have been implanted during open heartsurgery, so that the annuloplasty ring can be sewn into the valveannulus. Open heart surgery is a highly invasive procedure that requiresconnecting a heart and lung machine (to pump the patient's blood andbreathe for the patient), stopping the patient's heart, and cutting openthe thoracic cavity and heart organ. The procedure can expose thepatient to a high risk of infection and may result in a long anddifficult recovery. The recovery can be particularly difficult forpatients in less than optimal health due to the effects of sufferingfrom a heart valve defect such as regurgitation.

SUMMARY OF THE DISCLOSURE

Disclosed herein are apparatus, systems, and methods for repairing heartvalves through percutaneous transcatheter delivery, fixation, andadjustment of annuloplasty rings.

In one embodiment, an annuloplasty ring includes an outer hollow bodymember including a plurality of regions or segments. Adjacent regions orsegments cooperate with one another to enable the body member totransition from an elongate insertion geometry to an annular operablegeometry. The annuloplasty ring in the annular operable geometry can beexpanded by an expansion tool to increase an anterior-posterior (A-P)diameter of the annuloplasty ring to an expanded state in intimatecontact with tissue of a heart valve annulus. The annuloplasty ring alsoincludes an internal anchor member located at least partially within theouter hollow member. The internal anchor member includes a plurality ofanchors configured to fasten the annuloplasty ring to tissue of theheart valve annulus. The internal anchor member is configured to movethe plurality of anchors with respect to a plurality of windows or gapsin the outer hollow body member to selectively deploy the plurality ofanchors through the corresponding windows. The annuloplasty ring can becontracted from the expanded state to a contracted state to decrease theA-P diameter of the annuloplasty ring and decrease the A-P distance ofthe heart valve annulus to improve leaflet coaptation of the heart valveleaflets and reduce regurgitation through the heart valve.

In certain embodiments, methods are disclosed for percutaneoustranscatheter repair of a heart valve using the adjustable annuloplastyring.

In addition, or in other embodiments, a delivery system is disclosed forpercutaneous transcatheter delivery of the adjustable annuloplasty ring.

BRIEF DESCRIPTION OF THE DRAWINGS

Understanding that drawings depict only certain embodiments and are nottherefore to be considered to be limiting in nature, non-limiting andnon-exhaustive embodiments of the disclosure are described and explainedwith additional specificity and detail through the use of theaccompanying drawings.

FIG. 1A is a perspective view of an adjustable annuloplasty ringaccording to one embodiment. The annuloplasty ring is in an annular(D-shaped) operable geometry and a contracted state.

FIG. 1B is a perspective view of the adjustable annuloplasty ring ofFIG. 1A in an expanded state.

FIG. 1C is a schematic diagram illustrating a cutting pattern used forlaser processing a hypotube of the adjustable annuloplasty ring shown inFIGS. 1A and 1B.

FIG. 2A is a simplified schematic diagram illustrating a perspectiveview of an adjustable annuloplasty ring according to another embodiment.The annuloplasty ring is in an annular (D-shaped) operable geometry anda contracted state.

FIG. 2B is a simplified schematic diagram illustrating a perspectiveview of the adjustable annuloplasty ring of FIG. 2A in an expandedstate.

FIG. 3A is a simplified schematic diagram illustrating a perspectiveview of an adjustable annuloplasty ring according to another embodiment.The annuloplasty ring is in an annular (D-shaped) operable geometry andin an expanded state.

FIG. 3B is a simplified schematic diagram illustrating a perspectiveview of the adjustable annuloplasty ring of FIG. 3A in a contractedstate.

FIGS. 4A and 4B are a perspective view and a cross-sectional view,respectively, of a stepped connector of the adjustable annuloplasty ringof FIGS. 3A and 3B according to one embodiment.

FIG. 5A is a simplified schematic diagram illustrating a side view of aninternal anchor ribbon including the curved anchors shown in FIGS. 1Aand 1B according to one embodiment.

FIG. 5B is a schematic diagram illustrating a top view of the anchorscut into the internal anchor ribbon shown in FIG. 5A in the elongateinsertion geometry according to one embodiment.

FIG. 5C is a schematic diagram illustrating a side view of the internalanchor ribbon in the elongate insertion geometry and the anchors in acurled or curved deployed configuration according to one embodiment.

FIG. 5D is a schematic diagram illustrating a top view of an internalglide ribbon shown in FIG. 5A in an elongate insertion geometryaccording to one embodiment.

FIG. 5E is a schematic diagram illustrating a side view of the internalglide ribbon shown in FIG. 5D.

FIGS. 6A and 6B are simplified schematics illustrating cross-sectionside views of an annuloplasty ring before (FIG. 6A) and after (FIG. 6B)deployment of the anchors shown in FIGS. 5A-5C according to oneembodiment.

FIG. 7 is a schematic diagram illustrating a side view of an internalanchor member including linear anchors according to one embodiment.

FIG. 8A is a schematic diagram illustrating a trans-septal approach forendovascular delivery of an annuloplasty ring to the mitral valve of aheart according to one embodiment.

FIG. 8B is a schematic diagram illustrating an example retrogradeapproach of an annuloplasty ring to the mitral valve of a heartaccording to another embodiment.

FIG. 8C is a schematic diagram illustrating an example trans-apicalapproach of an annuloplasty ring to the mitral valve of a heartaccording to another embodiment.

FIGS. 9A, 9B, 9C, and 9D are schematic diagrams illustratingtranscatheter delivery of an annuloplasty ring from a delivery systemaccording to certain embodiments.

FIG. 10 is a schematic diagram illustrating a perspective, partialcross-sectional view of a heart during the expansion of an adjustableannuloplasty ring using a balloon expansion tool, preparatory toaffixation to the annulus of the mitral valve according to oneembodiment.

FIG. 11 is a schematic diagram illustrating a perspective, partialcross-sectional view of the heart during the expansion of an adjustableannuloplasty ring using a cage or basket expansion tool, preparatory toaffixation to the annulus of the mitral valve according to anotherembodiment.

FIGS. 12A and 12B are perspective views of an intimate contact tool of apercutaneous annuloplasty system according to one embodiment.

FIGS. 13A and 13B are perspective views of an intimate contact tool of apercutaneous annuloplasty system according to another embodiment.

FIGS. 14A and 14B are perspective views of an intimate contact tool of apercutaneous annuloplasty system according to one embodiment.

FIG. 15A is a perspective view of an angled snap of a ring closure lockaccording to one embodiment.

FIG. 15B is a top view of the angled snap of the ring closure lock ofFIG. 15A.

FIG. 15C is a perspective view of the angled snap of the ring closurelock of FIG. 15A.

FIGS. 16A and 16B are cross-section views of a receiving component of aring closure lock according to one embodiment.

FIG. 16C is an end view of the receiving component of the ring closurelock of FIGS. 16A and 16B according to one embodiment.

FIG. 17A is a perspective view of a proximal end handle of apercutaneous annuloplasty system according to one embodiment.

FIG. 17B is cross-section view of the proximal end handle of FIG. 17A.

FIG. 18 is a flowchart of a method for repairing a defective heart valveaccording to one embodiment.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The present disclosure provides systems and methods for repairing heartvalves through percutaneous transcatheter delivery and fixation ofannuloplasty rings to heart valves. The embodiments of annuloplastyrings can be configured in both an elongate insertion geometry that canbe inserted into a catheter tube and an operable geometry providing acurved and rigid or semi-rigid annular shape.

In certain embodiments, an annuloplasty ring in the operable geometrycan be expanded to an expanded state using an expansion tool. Theexpansion of the annuloplasty ring to the expanded state increases ananterior-posterior (A-P) diameter of the annuloplasty ring to positionthe annuloplasty ring in abutment with tissue of an annulus of a targetheart valve that is to be repaired. Following fixation of theannuloplasty ring to the annulus, the annuloplasty ring can becontracted from the expanded state to a contracted state to decrease theA-P diameter of the annuloplasty ring and decrease the A-P distance ofthe heart valve annulus, and thereby improve leaflet coaptation of theheart valve leaflets and reduce regurgitation through the heart valve.

In certain embodiments, an annuloplasty ring is delivered percutaneouslyto the mitral and/or tricuspid valve annulus of the heart. The disclosedembodiments apply, for example, to trans-septal, retrograde, ortrans-apical approaches for delivering annuloplasty rings to an annulusof a heart valve. For delivery of annuloplasty rings into the mitralvalve, percutaneous delivery may involve a retrograde approach from thefemoral artery, an antegrade approach via a trans-septal entry, or atrans-apical approach through the base or apex of the heart through theleft ventricle to the left atrium. Delivery of annuloplasty rings to thetricuspid valve may include an approach from the inferior or superiorvena cava.

Certain annuloplasty rings disclosed herein are small and flexibleenough to be percutaneously delivered, but can be put into a rigid orsemi-rigid ring shape and then securely anchored into the heart valveannulus without having to open up the chest. Disclosed embodimentsinclude annuloplasty rings, delivery systems, and methods for anchoringthe annuloplasty ring around the valve annulus and then adjusting an A-Pdistance of the annuloplasty ring.

Example Ring Embodiments with Biasing Elements

FIG. 1A is a simplified schematic diagram illustrating a perspectiveview of an adjustable annuloplasty ring 100 according to one embodiment.The annuloplasty ring 100 illustrated in FIG. 1A is in an annular(D-shaped) operable geometry in a contracted state. FIG. 1B is asimplified schematic diagram illustrating a perspective view of theadjustable annuloplasty ring 100 of FIG. 1A in an expanded state. Theannuloplasty ring 100 is configured to enable percutaneous,transcatheter annuloplasty to repair a heart valve. The annuloplastyring 100 may be fastened, percutaneously, to the annulus of the heartvalve while in the expanded state and then reduced to the contractedstate to decrease an A-P distance of the target valve and therebyimprove leaflet coaptation of the target valve and reduce regurgitationthrough the target valve.

Referring collectively to FIGS. 1A and 1B, the annuloplasty ring 100includes a body member 101 having a plurality of regions 102 a, 102 b,102 c (collectively 102), biasing elements 103 a, 103 b (collectively103), a plurality of anchors 104, a ring closure lock 106, and a pivot108. In FIGS. 1A and 1B, as well as in other embodiments disclosedherein, the body member 101, including the plurality of regions 102, isarranged in a “D-shape” in the operable geometry. The D-shapedannuloplasty ring 100 has a certain geometrical ratio that is inconformance (or approximate conformance) with the anatomical geometry ofthe human mitral valve annulus. For example, in certain embodiments theratio of the A-P distance to the commissure-commissure (C-C) distance ofthe annuloplasty ring 100 when implanted (i.e., in the contracted state)is in a range between about 0.60 and about 0.70. In one embodiment, theimplanted ratio of the A-P distance to the C-C distance is about 0.62.

Although the illustrated embodiment of an annuloplasty ring 100 of FIGS.1A and 1B is a D-shaped operable geometry, artisans will recognize fromthe disclosure herein that other annular-shaped operable geometries mayalso be used. For example, circular or oval operable geometries may beused.

The body member 101 may include a hollow hypotube (or outer hollowmember). The hypotube may be cut from, for example, a tube to form theplurality of regions 102. The cuts may define a shape and/orcharacteristics of the body member 101. For example, the laser cuts maydefine the plurality of regions 102 (and define how the plurality ofregions 102 interact), anchor windows 110, and/or the biasing elements103.

In certain embodiments, the body member 101 may include a shape memory(e.g., Nitinol) hypotube into which a plurality of cuts and/or segmentsmay be laser cut to define a size, shape, and/or characteristics of theplurality of regions 102. The shape memory hypotube may be heat set to a“memorized” annular shape (e.g., the D-shaped operable geometry). Theshape memory hypotube may be superelastic such that applying sufficientstress may place the body member 101, including the plurality of regions102, into the elongate insertion geometry and releasing the stressallows the body member 101, including the plurality of regions 102, toresume the D-shaped operable geometry.

In addition to the operable geometry shown in FIGS. 1A and 1B, the bodymember 101 is transitionable from an elongate insertion geometry (see,e.g., FIG. 9A) to the annular operable geometry shown in FIGS. 1A and1B. The elongate insertion geometry allows the annuloplasty ring 100 tobe inserted into and passed through a catheter for percutaneous passageof the annuloplasty ring 100 into the heart of a patient. A transitionfrom an elongate insertion geometry to an annular operable geometry isillustrated in FIGS. 9A-9D, and discussed below with reference to thesame.

Once in an annular operable geometry as shown in FIGS. 1A and 1B, theannuloplasty ring 100 has a contracted state as shown in FIG. 1A and anexpanded state as shown in FIG. 1B. The biasing elements 103 areconfigured to be expanded to increase the A-P distance of theannuloplasty ring 100 to an expanded state. The A-P distance AP1 of thecontracted state of FIG. 1A is enlarged a distance d such that the A-Pdistance AP2 of the expanded state FIG. 1B is larger (AP2=AP1+d).Expansion of the biasing elements 103 allows the body member 101 to beexpanded to an expanded state. In situ in the heart, expansion of thebody member 101 to the expanded state may enlarge the annuloplasty ring100 to a size conforming, or approximately conforming, to an annulus ofa target heart valve to be repaired. Expansion of the body member 101may be accomplished by an expansion tool, such as a balloon, a cage, oranother tool as shown in FIGS. 10, 11, 12A-12B, 13A-13B, and 14A-14B,and described below with reference to the same. In the illustratedembodiment of FIGS. 1A and 1B, a biasing element 103 a disposed betweena first posterior region 102 a and an anterior region 102 c and abiasing element 103 b disposed between a second posterior region 102 band the anterior region 102 c enable a desired expansion from thecontracted state shown in FIG. 1A to the expanded state shown in FIG.1B.

The expanded state of FIG. 1B may be such that the annuloplasty ring 100is disposed in abutment with, or in intimate contact with, the annulusof the target valve. Disposing the annuloplasty ring 100 in intimatecontact with the annulus enhances an anchoring process in which theplurality of anchors 104 is deployed to fasten the annuloplasty ring 100to the annulus. Once the annuloplasty ring 100 is fastened to theannulus, the annuloplasty ring 100 can be contracted from the expandedstate of FIG. 1B back to the contracted state of FIG. 1A to reduce adiameter of the annulus of the target valve.

Contraction of the annuloplasty ring 100 from the expanded state to thecontracted state decreases the A-P distance of the annuloplasty ring 100and, with the plurality of anchors 104 securing the annuloplasty ring100 to the annulus, also decreases an A-P distance of the target valveto improve leaflet coaptation and reduce regurgitation through thetarget valve. In the illustrated embodiment of FIGS. 1A and 1B,contraction of the annuloplasty ring 100 from the expanded state to thecontracted state is accomplished by the biasing elements 103. Thebiasing elements 103 may bias the annuloplasty ring 100 toward thecontracted state such that expansion of the annuloplasty ring 100 to theexpanded state stores potential energy in the biasing elements 103.Releasing the biasing elements 103 (e.g., releasing or otherwiseremoving an expansion tool and/or expansion force) releases the storedpotential energy and thereby forces movement of the first posteriorregion 102 a and the second posterior region 102 b of the body member101 toward the anterior region 102 c of the body member 101 to decreasethe A-P distance of the annuloplasty ring 100 to the contracted state.In other words, the biasing elements 103, upon release, activelytransition the annuloplasty ring 100 from the expanded state to thecontracted state.

A typical range for change of the A-P distance d (between the expandedstate and the contracted state) is between 3 mm and 5 mm. The range of dmay depend on the overall size of the annuloplasty ring 100. Forexample, for a final geometry of the annuloplasty ring 100 that is 26mm, a change distance d of about 3 mm may be desired. As anotherexample, for a final geometry of the annuloplasty ring 100 that is 36mm, a change distance d of about 5 mm may be desired.

The biasing elements 103 of the illustrated annuloplasty ring 100 ofFIGS. 1A and 1B may be a spiral cut or helical portion of the bodymember 101 that is laser cut into the body member 101. The spiral cut orhelical portion, because it is cut into the body member 101, is abiasing element 103 that is integral to the body member 101. The spiralcut portion of the body member 101, as shown in FIG. 1B, may form orotherwise define a spiral shape configured to expand to allow theanterior region 102 c to move away from the first posterior region 102 aand from the second posterior region 102 b, thereby increasing the A-Pdistance of the annuloplasty ring 100. Also, the spiral cut or helicalportion of the body member 101 may be biased toward a relaxed position,or the contracted state as shown in FIG. 1A, such that expansion of thespiral cut or helical portion stores potential energy and release of anexpansion force results in a release of potential energy and contractiontoward the contracted state.

Other integral biasing elements 103 may be utilized. For example, adiamond cut pattern cut into the body member 101 may allow desiredexpansion and biasing toward the contracted state. In anotherembodiment, a corrugated pattern (e.g., folds) may be formed in the bodymember 101. The corrugated pattern may allow desired expansion toincrease the A-P distance of the annuloplasty ring 100 and may be biasedtoward the contracted state.

In addition to integral biasing elements 103 (formed integrally in thebody member 101 of the annuloplasty ring 100), other biasing elements103 may be used that are not integral to the body member 101. Forexample, FIGS. 2A and 2B illustrate an embodiment in which the biasingelement 103 is a spring and which is not integral to the body member101, as discussed below with reference to the same figures. In stillother embodiments, the biasing element 103 may comprise a nonintegralbiasing component (e.g., a spring) to complement or enhance operation ofan integrally formed biasing element.

The plurality of anchors 104, as noted above, is configured to securethe annuloplasty ring 100 to the annulus of the heart valve. In certainembodiments, the anchors 104 are sufficient such that additionalsuturing of the annuloplasty ring 100 to the valve annulus is notneeded. In FIG. 1A the anchors 104 are within the body member 101 in aninsertion geometry. In FIG. 1B, the anchors 104 are curved in theillustrated deployed configuration. The anchors 104 in other embodimentsmay include other shapes, such as linear or helical deployedconfigurations. In certain embodiments, the anchors 104 include a shapememory material (e.g., Nitinol) that is heat set to a deployedconfiguration (e.g., curved configuration, linear configuration, orhelical configuration). Artisans will recognize from the disclosureherein that combinations of different deployed anchor configurations mayalso be used.

The anchors 104 are superelastic such that applying sufficient stressplaces the anchors 104 into an introduction configuration and releasingthe stress allows the anchors 104 to resume their respective deployedconfigurations. In certain embodiments, the anchors 104 lay flat againstthe body member 101 in the introduction configuration during insertionof the annuloplasty ring 100 through the catheter. As discussed below,in other embodiments, the anchors 104 are retracted inside the hollowbody member 101 of the annuloplasty ring 100 in the introductionconfiguration during insertion of the annuloplasty ring 100 through thecatheter. In such embodiments, the anchors 104 may be selectivelydeployed at a desired time (e.g., after the annuloplasty ring 100 isproperly positioned against, or in abutment with, the annulus of theheart valve). In certain embodiments, the superelastic property of theanchors 104 is used to self-propel the anchors 104 into the annulus ofthe heart valve. The anchors 104 may be configured to be deployed fromwithin the body member 101 through anchor windows 110 in the bodywindow.

The ring closure lock 106 is used to secure two open ends of theannuloplasty ring 100 to form a closed ring of the operable geometry. Incertain embodiments, the ring closure lock 106 includes a female snapand a male snap. As discussed in greater detail below, the annuloplastyring 100 may be “snap locked” using wires or sutures to pull a male snapinto a female snap. The ring closure lock 106 of the illustratedannuloplasty ring 100 of FIGS. 1A and 1B is disposed at a posterior sideof the annuloplasty ring 100. The ring closure lock 106 allows an angledcoupling of the two ends, for example at an apex of a curved side of aD-shaped annular operable geometry. A bent or angled ring closure lock106, according to one embodiment, is shown in FIGS. 15A-15B, anddiscussed in greater detail below with reference to the same.

The pivot 108 is used to automatically rotate the annuloplasty ring 100after it exits the catheter within the heart to align the plane of theannuloplasty ring 100 (in the annular operable geometry) with the planeof the heart valve. The annuloplasty ring 100 is pushed from thecatheter in a direction that is substantially perpendicular to the planeof the heart valve (e.g., parallel to the general direction of bloodflow through the valve). Upon exiting the catheter, the annuloplastyring 100 is rotated at or about the pivot 108 to allow properpositioning of the annuloplasty ring 100 against the annulus. With theannuloplasty ring 100 properly oriented in alignment with the plane ofthe heart valve, the annuloplasty ring 100 can be expanded to theexpanded state. For example, an expansion tool can be used to expand theannuloplasty ring 100, as shown in FIGS. 10, 11, 12A-12B, 13A-13B, and14A-14B, and discussed below with reference to the same. Theannuloplasty ring 100 in the expanded state can be pressed against thevalve annulus before deploying the anchors 104, and an act of deployingthe anchors 104 drives the anchors 104 into the tissue. A positioningtool may facilitate expansion and/or proper positioning/orientation ofthe annuloplasty ring 100 against the heart valve annulus. An intimatecontact tool, such as a tri-pod tool or a bi-pod tool, shown for examplein FIGS. 12A-12B, 13A-13B, and 14A-14B, and discussed below withreference to the same, may be used to position the annuloplasty ring 100in abutment against the annulus of the target heart valve, or otherwisein intimate contact with the annulus of the target heart valve. Inaddition, fluoroscopy, ultrasound, and/or other imaging techniques maybe used to assist in proper positioning of the annuloplasty ring 100against the heart valve annulus.

Although not shown in FIGS. 1A and 1B, certain ring embodiments mayinclude a selectively adjustable member for changing the size and/orshape of the annuloplasty ring 100 postoperatively to compensate forchanges in the size of the heart and/or the treated heart valve.Examples of a selectively adjustable member are provided in U.S. patentapplication Ser. No. 13/198,582, filed Aug. 4, 2011, and titledPERCUTANEOUS TRANSCATHETER REPAIR OF HEART VALVES, which is herebyincorporated herein by reference in its entirety.

FIG. 1C is a schematic diagram illustrating a cutting pattern 116 usedfor laser processing a hypotube to form the body member 101 of theadjustable annuloplasty ring 100 shown in FIGS. 1A and 1B. The pattern116 enables a hypotube or outer tube (also referred to herein as an“outer hollow member”) to be cut for use as a body member 101 of anannuloplasty ring 100 according to one embodiment. The cutting pattern116 corresponds to the entire body member 101 as if the body member 101were cut along a longitudinal axis and unrolled. The cutting pattern 116enables cutting the hypotube to form the plurality of regions 102 andthe integral biasing elements 103. The cutting pattern 116 shown in FIG.1C defines the configuration of the plurality of regions 102 and how theregions 102 interact with adjacent regions as the body member 101transitions from the elongate insertion geometry shown to the annularoperable geometry.

The cutting pattern 116 also enables cutting the hypotube to form one ormore through holes 120, 121 at each end to allow one or more pins (notshown) to couple male and/or female components of the ring closure lock106 to respective ends of the body member 101. The cutting pattern 116may also enable cutting the hypotube to form anchor windows 110 throughwhich the plurality of anchors 104 are deployed.

FIG. 2A is a simplified schematic diagram illustrating a perspectiveview of an adjustable annuloplasty ring 200 according to anotherembodiment. The annuloplasty ring 200 is in an annular (D-shaped)operable geometry and a contracted state. FIG. 2B is a simplifiedschematic diagram illustrating a perspective view of the adjustableannuloplasty ring 200 of FIG. 2A in an expanded state. The annuloplastyring 200 is configured to enable percutaneous, transcatheterannuloplasty to repair a heart valve.

Referring collectively to FIGS. 2A and 2B, the annuloplasty ring 200includes a body member 201 having a plurality of regions 202 a, 202 b,202 c (collectively 202), biasing elements 203 a, 203 b (collectively203), a plurality of anchors 204, a ring closure lock 206, and a pivot208. The body member 201 is a “D-shape” in the operable geometry, butartisans will recognize from the disclosure herein that otherannular-shaped operable geometries may also be used. For example,circular or oval operable geometries may be used. Different from theannuloplasty ring 100 of FIGS. 1A-1B, the ring closure lock 206 isdisposed on the anterior side of the annuloplasty ring 200 (rather thanthe posterior side).

In addition to the operable geometry shown in FIGS. 2A and 2B, the bodymember 201 is transitionable from an elongate insertion geometry (see,e.g., FIG. 9A) to the annular operable geometry shown in FIGS. 2A and2B. The elongate insertion geometry allows the annuloplasty ring 200 tobe inserted into and passed through a catheter for percutaneous passageof the annuloplasty ring 200 into the heart of a patient. A transitionfrom an elongate insertion geometry to an annular operable geometry isillustrated in FIGS. 9A-9D, and discussed below with reference to thesame.

Once in an annular operable geometry, the annuloplasty ring 200 has acontracted state as shown in FIG. 2A and an expanded state as shown inFIG. 2B. The biasing elements 203 are configured to allow expansion ofthe body member 201 to increase the A-P distance of the annuloplastyring 200 to an expanded state. In situ within the heart, expansion ofthe body member 201 to the expanded state may enlarge the annuloplastyring 200 to a size conforming, or approximately conforming, to anannulus of a target heart valve to be repaired. Expansion of the bodymember 201 may be accomplished by an expansion tool, such as a balloon,a cage, or another expansion tool as shown in FIGS. 10, 11, 12A-12B,13A-13B, and 14A-14B, and described below with reference to the same. Inthe illustrated embodiment of FIGS. 2A and 2B, a biasing element 203 adisposed between a first anterior region 202 a and a posterior region202 c and a biasing element 203 b disposed between a second anteriorregion 202 b and the posterior region 202 c enable a desired expansionfrom the contracted state shown in FIG. 2A to the expanded state shownin FIG. 2B.

The expanded state of FIG. 2B may be such that the annuloplasty ring 200is disposed in abutment with, or in intimate contact with, the annulusof the target valve. Disposing the annuloplasty ring 200 in intimatecontact with the annulus enhances an anchoring process in which theplurality of anchors 204 is deployed to fasten the annuloplasty ring 200to the annulus.

Once the annuloplasty ring 200 is fastened to the annulus, theannuloplasty ring 200 can be contracted from the expanded state of FIG.2B back to the contracted state of FIG. 2A to reduce a diameter of theannulus of the target valve. Contraction of the annuloplasty ring 200may include the first and second anterior regions 202 a, 202 b of thebody member 201 moving in a telescopic manner into the posterior region202 c as the biasing members 203 force movement of the first and secondanterior regions 202 a, 202 b of the body member 201 toward theposterior region 202 c. Contraction of the annuloplasty ring 200 fromthe expanded state to the contracted state decreases the A-P distance ofthe annuloplasty ring 200 and, with the plurality of anchors 204securing the annuloplasty ring 200 to the annulus, also decreases theA-P distance of the target valve to improve leaflet coaptation andreduce regurgitation through the target valve.

In the illustrated embodiment of FIGS. 2A and 2B, contraction of theannuloplasty ring 200 from the expanded state to the contracted state isaccomplished by the biasing elements 203. The biasing elements 203 maybias the annuloplasty ring 200 toward the contracted state such thatexpansion of the annuloplasty ring 200 to the expanded state storespotential energy in the biasing elements 203. Releasing the biasingelements 203 (e.g., releasing or otherwise removing an expansion tooland/or expansion force) releases the stored potential energy and therebyforces movement of the first anterior region 202 a and the secondanterior region 202 b of the body member 201 toward the anterior region202 c of the body member 201 to decrease the A-P distance of theannuloplasty ring 200 to the contracted state. In other words, thebiasing elements 203, upon release, actively transition the annuloplastyring 200 from an expanded state to the contracted state.

The biasing elements 203 of the illustrated annuloplasty ring 200 ofFIGS. 2A and 2B may include springs or another similar element that isnonintegral to the body member. The springs of the biasing elements 203allow the anterior regions 202 a, 202 b to move away from the firstposterior region 202 c, thereby increasing the A-P distance of theannuloplasty ring 200.

The A-P distance AP1 of the contracted state of FIG. 2A is enlarged adistance d upon expansion of the annuloplasty ring 200 such that the A-Pdistance AP2 of the expanded state FIG. 2B is larger (AP2=AP1+d). Thesprings of the biasing elements 203 may be biased toward a relaxedposition, or the contracted state as shown in FIG. 2A, such thatexpansion of the springs stores potential energy and release of thesprings results in a release of potential energy and contraction towardthe contracted state.

The plurality of anchors 204 are configured to secure the annuloplastyring 200 to the annulus of the heart valve. In FIGS. 2A and 2B, theanchors 204 are curved in the illustrated deployed configuration. Theanchors 204 in other embodiments may include other shapes, such aslinear or helical deployed configurations. In certain embodiments, theanchors 204 include a shape memory material (e.g., Nitinol) that is heatset to a deployed configuration (e.g., curved configuration, linearconfiguration, or helical configuration). Artisans will recognize fromthe disclosure herein that combinations of different deployed anchorconfigurations may also be used.

The anchors 204 may be superelastic such that applying sufficient stressplaces the anchors 204 into an introduction configuration and releasingthe stress allows the anchors 204 to resume their respective deployedconfigurations. In certain embodiments, the anchors 204 lay flat againstthe body member 201 in the introduction configuration during insertionof the annuloplasty ring 200 through the catheter. As discussed below,in other embodiments, the anchors 204 are retracted inside a hollow bodymember 201 of the annuloplasty ring 200 in the introductionconfiguration during insertion of the annuloplasty ring 200 through thecatheter. In such embodiments, the anchors 204 may be selectivelydeployed at a desired time (e.g., after the annuloplasty ring 200 isproperly positioned against, or in abutment with, the annulus of theheart valve). In certain embodiments, the superelastic property of theanchors 204 is used to self-propel the anchors 204 into the annulus ofthe heart valve.

The ring closure lock 206 is used to secure two open ends of theannuloplasty ring 200 to form a closed ring of the operable geometry.Different from the annuloplasty ring 100 of FIGS. 1A-1B, the ringclosure lock 206 is disposed on the anterior side of the annuloplastyring 200 (rather than the posterior side). In certain embodiments, thering closure lock 206 includes a female snap and a male snap. Theannuloplasty ring 100 may be “snap locked” using wires or sutures topull a male snap into a female snap.

The pivot 208 facilitates rotation of the annuloplasty ring 200 after itexits the catheter within the heart to align the plane of theannuloplasty ring 200 (in the annular operable geometry) with the planeof the heart valve, as previously described.

FIG. 3A is a simplified schematic diagram illustrating a perspectiveview of an adjustable annuloplasty ring 300 according to anotherembodiment. The annuloplasty ring 300 is in an annular (D-shaped)operable geometry and an expanded state. FIG. 3B is a simplifiedschematic diagram illustrating a perspective view of the adjustableannuloplasty ring 300 of FIG. 3A in a contracted state. The annuloplastyring 300 is configured to enable percutaneous, transcatheterannuloplasty to repair a heart valve.

Referring collectively to FIGS. 3A and 3B, the annuloplasty ring 300includes a body member 301 having a plurality of regions 302 a, 302 b,302 c (collectively 302), a plurality of anchors 304, a ring closurelock 306, and a pivot 308, similar to previously described embodiments.The annuloplasty ring 300 is transitionable from an elongate insertiongeometry (see, e.g., FIG. 9A) to the annular operable geometry shown inFIGS. 3A and 3B. The elongate insertion geometry allows the annuloplastyring 300 to be inserted into and passed through a catheter forpercutaneous passage of the annuloplasty ring 300 into the heart of apatient, as illustrated in FIGS. 9A-9D, and discussed below withreference to the same.

The plurality of regions 302 of the illustrated annuloplasty ring 300 ofFIGS. 3A and 3B may be separate, individual segments. The segments 302may be coupled together by stepped connectors 330 a, 330 b (collectively330) in the annular operable geometry. The stepped connectors 330 areconfigured to enable the body member 301 to be adjustable to decreasethe A-P distance of the annuloplasty ring 300 from an expanded state asshown in FIG. 3A to a contracted state as shown in FIG. 3B. The steppedconnectors 330 initially couple the posterior segment 302 c to each of afirst anterior segment 302 a and a second anterior segment 302 b in theexpanded state of FIG. 3A, conforming, or approximately conforming, toan annulus of a target heart valve to be repaired. The expanded state ofFIG. 3A may be such that the annuloplasty ring 300 is disposed inabutment with, or in intimate contact with, the annulus of the targetvalve, thereby enhancing an anchoring process in which the plurality ofanchors 304 are deployed to fasten the annuloplasty ring 300 to theannulus.

Once the annuloplasty ring 300 is fastened to the annulus, theannuloplasty ring 300 can be contracted from the expanded state of FIG.3A to the contracted state of FIG. 3B to reduce a diameter of theannulus of the target valve. Contraction of the annuloplasty ring 300may include the stepped connectors 330 moving in a telescopic mannerinto the posterior region 302 c as the first and second anterior regions302 a, 302 b of the body member 301 move toward the posterior region 302c. Contraction of the annuloplasty ring 300 from the expanded state tothe contracted state decreases the A-P distance of the annuloplasty ring300 and, with the plurality of anchors 304 securing the annuloplastyring 300 to the annulus, also decreases an A-P distance of the targetvalve to improve leaflet coaptation and reduce regurgitation through thetarget valve. The stepped connectors 330 allow for multiple degrees ofadjustment. For example a stepped connector having two engagement steps(see engagement steps 402 in FIGS. 4A and 4B) may allow two degrees ofadjustment, as discussed more fully below.

In the illustrated embodiment of FIGS. 3A and 3B, contraction of theannuloplasty ring 300 from the expanded state to the contracted statemay be accomplished percutaneously through use of sutures or wires toforce the posterior segment 302 c toward the first and second anteriorsegments 302 a, 302 b and vice versa.

In certain embodiments, a biasing element (not shown in FIGS. 3A and 3B)may bias the annuloplasty ring 300 toward the contracted state and aidin contraction of the annuloplasty ring 300 from the expanded state tothe contracted state. In other embodiments, a biasing element may enableexpansion from an initial state to an expanded state and a steppedconnector 330 may operate to ensure expansion from the contracted stateis restricted.

Different from the embodiments of FIGS. 1A-1C and 2A and 2B, theannuloplasty ring 300 of FIGS. 3A and 3B is initially in an expandedstate upon transition to the annular operable geometry. In other words,the initial A-P distance AP1 of the annuloplasty ring 300 is sufficientto conform or substantially conform to the A-P distance of a targetvalve. The A-P distance AP1 of the expanded state of FIG. 3A isdecreased a distance d upon contraction of the annuloplasty ring 300such that the A-P distance AP2 of the contracted state FIG. 3B issmaller (AP2=AP1−d). The decrease of the A-P distance, with the anchorsfastening the annuloplasty ring 300 to the annulus of the valve,decreases the A-P distance of the target valve to improve leafletcoaptation of the target valve and reduce regurgitation through thetarget valve.

FIGS. 4A and 4B are a perspective view and a cross-sectional view,respectively, of a male component 400 of a stepped connector 330 of theadjustable annuloplasty ring 300 of FIGS. 3A and 3B according to oneembodiment. A corresponding female component (not shown) may beconfigured to receive the male component 400 to form the steppedconnector 330. The stepped connector 330 may include two engagementsteps 402 a, 402 b (collectively 402) to allow two degrees of adjustmentand/or gradual adjustment. As shown in FIG. 4B, a cable 404 or suturemay couple to the male component 400 of the stepped connector 330. Thecable 404 or suture may enable a force to move the male component 400 ina telescopic manner into a female component of the stepped connector330. Contraction of the annuloplasty ring 300 until engagement of afirst engagement step 402 a within the female component may secure theannuloplasty ring 300 in a partial contracted state. Further contractionof the annuloplasty ring 300 to engagement of a second engagement step402 b within the female component may secure the annuloplasty ring 300in the contracted state. In this manner, the stepped connector 330enables two degrees of adjustment (and for gradual adjustment) of theA-P distance of the annuloplasty ring.

Example Embodiments of Anchors

FIG. 5A is a simplified schematic diagram illustrating a side view of aninternal anchor ribbon 500 including the curved anchors 104 shown inFIGS. 1A and 1B according to one embodiment. In certain embodiments,deployment of the anchors 104 is accomplished using an internal anchormember, such as anchor ribbon 500, that is selectively movable within ahollow tube of the body member 101 (FIG. 1A). The curved anchors 104 maybe affixed (e.g., laser welded) to the internal anchor ribbon 500 ordirectly cut into the internal anchor ribbon 500. Like the anchors 104,the internal anchor ribbon 500 may include a superelastic shape memorymaterial (e.g., Nitinol). The shape memory of the anchor ribbon 500 maybe heat set to the same memorized annular shape as the plurality ofregions 102 of the body member 101 in the contracted state of theannular operable geometry, as shown in FIGS. 1A and 1B.

The internal anchor ribbon 500 may be slid (e.g., using wires or suturesaccessible through the catheter) within the hollow body member 101 ofthe annuloplasty ring 100. To reduce friction between the internalanchor ribbon 500 and the body member 101, certain ring embodimentsinclude an internal glide ribbon 510. The internal glide ribbon 510 mayinclude a low-friction material (e.g., as a coating or covering) such asPTFE or other polymer. In addition, or in other embodiments, theinternal glide ribbon 510 includes a superelastic shape memory material(e.g., Nitinol) that is heat set to the same memorized annular shape asthe body member 101. Thus, certain embodiments include three D-shapedsuperelastic members (the outer tube of the body member 101, theinternal anchor ribbon 500, and the internal glide ribbon 510), whichcooperate to increase the rigidity of the annuloplasty ring 100.

FIG. 5B is a schematic diagram illustrating a top view of the anchors104 cut into the internal anchor ribbon 500 shown in FIG. 5A in theelongate insertion geometry according to one embodiment. In thisexample, a laser is used to cut the anchors 104 along a first side 512,a second side 514 (e.g., in a pointed or tip shape), and a third side516, while leaving a fourth side 518 of the anchor 104 uncut andattached to the internal anchor ribbon 500. After cutting, the anchors104 are heat set to the desired memorized shape for the deployedconfiguration. For example, FIG. 5C is a schematic diagram illustratinga side view of the internal anchor ribbon 500 in the elongate insertiongeometry and the anchors 104 in a curled or curved deployedconfiguration according to one embodiment. The amount of curvature inthe deployed configuration of the anchors 104 may depend on theparticular application. In the example shown in FIG. 5C, the anchors 104fold back on themselves such that the prong or tip 520 points parallelto or away from the internal anchor ribbon 500. FIG. 5D is a schematicdiagram illustrating a top view of the internal glide ribbon 510, andFIG. 5E is a schematic diagram illustrating a side view of the internalglide ribbon 510, in the elongate insertion geometry according to oneembodiment.

FIGS. 6A and 6B are simplified schematics illustrating cross-sectionside views of an annuloplasty ring 600 before (FIG. 6A) and after (FIG.6B) deployment of the anchors 104 shown in FIGS. 5A-5C according to oneembodiment. For illustrative purposes, the annuloplasty ring 600 inFIGS. 6A and 6B is shown in an elongate insertion geometry. Artisanswill recognize from the disclosure herein, however, that the anchors 104are generally deployed when the annuloplasty ring 600 is in the annularoperable geometry.

The illustrated annuloplasty ring 600 includes an outer tube 610 (e.g.,formed by the body member 101 shown in FIG. 1) including a plurality ofanchor deployment windows 612. During the manufacturing of theannuloplasty ring 600, and before the annuloplasty ring 600 is loadedinto the catheter, the internal anchor ribbon 500 and the internal glideribbon 510 are inserted into the outer tube 610 in a position where theanchors 104 are prevented from exiting through the windows 612. As shownin FIG. 6A, inserting the internal anchor ribbon 500 into the outer tube610 prevents the anchors from assuming their fully curved deployedconfiguration.

For deploying the anchors 104, the internal anchor ribbon 500 mayinclude (or may be attached to) a hook or loop 614 for engaging a wireor suture 616 that may be pulled by a user through the catheter (e.g.,in the direction of arrow 618 in FIG. 6A) to move the tip of each anchor104 to a corresponding window 612. In certain embodiments, the anchors104 and windows 612 are arranged such that the tip of each anchor 104reaches its respective window 612 at substantially the same time as theother anchor/window pairs. As shown in FIG. 6B, once the tips of theanchors 104 reach the respective windows 612, the superelasticity of theanchors 104 propels the internal anchor ribbon 500 in the oppositedirection (as indicated by arrow 620) as the anchors 104 spring out thewindows 612 (as indicated by arrow 622) to resume their curvedconfigurations. As the anchors 104 drive through the windows 612 theanchors 104 drive into surrounding tissue (e.g., the heart valveannulus). The superelasticity of the anchors 104 allows the anchors 104to be self-propelled into the tissue adjacent or proximate to theannuloplasty ring 600.

FIG. 7 is a simplified schematic diagram illustrating a side view of aninternal anchor member 700 including linear anchors 710 according to oneembodiment. The linear anchors 710 may be affixed (e.g., laser welded)to the internal anchor member 700. In the embodiment shown in FIG. 7,however, the internal anchor member 700 and linear anchors 710 are cutfrom a single superelastic shape memory (e.g., Nitinol) hypotube. FIG.7, for example, shows remaining tubular portions 712 after the hypotubeis cut to form prongs 714 of the linear anchors 710. The remainingtubular portions 712 facilitate sliding (e.g., using wires or suturesaccessible through the catheter) the internal anchor member 700coaxially within the hollow tube of the annuloplasty ring (e.g., withinthe annuloplasty ring 600 shown in FIG. 6).

The internal anchor member 700 is heat set to the same memorized annularshape as the annuloplasty ring 600. The anchor prongs 714 can be heatset to protrude outward through windows cut in the annuloplasty ring600. Barbs 716 may be laser welded to the prongs 714 to form the linearanchors 710. The linear anchors 710 are retracted/deployed by slidingthe internal anchor member 700 within the annuloplasty ring 600.

Example Deployment Approaches

As discussed above, the annuloplasty ring embodiments disclosed hereinare configured for percutaneous transcatheter delivery and fixation toheart valves. The annuloplasty rings may be delivered through a catheterto the mitral valve, for example, using a trans-septal approach, aretrograde approach, or a trans-apical approach. For example, FIG. 8A isa schematic diagram illustrating a trans-septal approach forendovascular delivery of an annuloplasty ring (not shown) to the mitralvalve 810 of a heart 800 according to one embodiment. For illustrativepurposes, a partial cross-section of the heart 800 is illustrated toshow the right atrium RA, right ventricle RV, left atrium LA, and leftventricle LV. For clarity, certain features (e.g., papillary muscles andchordae tendineae) are not shown. In the trans-septal approach shown inFIG. 8A, the left atrium LA is approached by advancement of a catheter812 through the inferior vena cava 814, into the right atrium RA, acrossthe interatrial septum 816, and into the left atrium LA. Theannuloplasty ring may then be delivered through the catheter 812 intothe atrium and anchored to the annulus of the mitral valve 810.

As shown in FIG. 8A, the catheter 812 is delivered percutaneously intothe heart 800. A guiding sheath (not shown) may be placed in thevasculature system of the patient and used to guide the catheter 812 andits distal end 818 to a desired deployment site. In some embodiments, aguide wire (not shown) is used to gain access through the superior orinferior vena cava 814, for example, through groin access for deliverythrough the inferior vena cava 814. The guiding sheath may be advancedover the guide wire and into the inferior vena cava 814 shown in FIG.8A. The catheter 812 may be passed through the right atrium RA andtoward the interatrial septum 816. Once the distal end 818 of thecatheter 812 is positioned proximate to the interatrial septum 816, aneedle or piercing member (not shown) is advanced through the catheter812 and used to puncture the fossa ovalis or other portion of theinteratrial septum 816. In some embodiments, the catheter 812 isdimensioned and sized to pass through the fossa ovalis without requiringa puncturing device. That is, the catheter 812 may pass through thenatural anatomical structure of the fossa ovalis into the left atriumLA.

Similarly, any chamber (LV, RV, LA, RA) of the heart 800 may beapproached through the inferior vena cava 814. For example, the rightventricle RV may be approached through the inferior vena cava 814, intothe right atrium RA, and through the tricuspid valve 820. A variety ofother endovascular approaches may also be used.

FIG. 8B is a schematic diagram illustrating an example retrogradeapproach of an annuloplasty ring (not shown) to the mitral valve 810 ofa heart 800 according to another embodiment. In FIG. 8B, a femoralapproach is shown wherein the delivery catheter 812 is advanced throughthe aorta 822 and the aortic valve 824. Typically, the catheter 812 isadvanced through a sheath positioned within the femoral artery (notshown). Under fluoroscopy or other methods of guidance, the distal endof the catheter 812 is guided within the left ventricle LV and turned(e.g., as shown with a “U-turn” 826) within the left ventricle LV so asto pass through the leaflets of the mitral valve 810 and into the leftatrium LA. After verification of the appropriate positioning of thecatheter 812, a guide wire (not shown) may be inserted through thecatheter 812 into the left atrium LA, which may then be used to guideone or more other catheters into the left atrium LA for delivering andanchoring the annuloplasty ring to the annulus of the mitral valve 810.

FIG. 8C is a schematic diagram illustrating an example trans-apicalapproach of an annuloplasty ring (not shown) to the mitral valve 810 ofa heart 800 according to another embodiment. In this example, thecatheter 812 is shown passing through the apex 830 of the heart 800,through the left ventricle LV, through the leaflets of the mitral valve810, and into the left atrium. The annuloplasty ring may be deliveredthrough the catheter 812 into the left atrium LA and anchored to theannulus of the mitral valve 810. In one embodiment, a needle or trocarmay be used to puncture through the apex 830 to create a small openingthrough which a guide wire (not shown) can be inserted through the leftventricle LV into the left atrium LA. Then, the guide wire may be usedto guide successively larger and stiffer catheters so as to graduallyincrease the size of the opening in the apex 830 of the heart 800.

FIGS. 9A, 9B, 9C, and 9D are schematic diagrams illustratingtranscatheter delivery of an annuloplasty ring 902 from a deliverysystem 900 according to certain embodiments. FIG. 9A illustrates aperspective view of a distal end 910 of the delivery system 900. FIG. 9Ais a perspective view of the annuloplasty ring 902 in the elongateinsertion geometry and partially deployed from the distal end 910 of adelivery catheter 914 in a first deployment stage. In the first stage,the annuloplasty ring 902 may be still substantially in the elongateinsertion geometry. As shown in FIG. 9A, a first suture 919 for snappingtogether the ends of the annuloplasty ring 902 passes through a malesnap 912 of a ring closure lock 950 (shown in FIG. 9C).

FIG. 9B is a perspective view of the annuloplasty ring 902 in a secondstage of partial deployment from the delivery catheter 914. In thesecond stage, the portion of the annuloplasty ring 902 that has exitedthe delivery catheter 914 has begun to transition (due to the shapememory materials used in the annuloplasty ring 902) from the elongateinsertion geometry to the annular operable geometry.

FIG. 9C is a perspective view of the annuloplasty ring 902 in a thirdstage of deployment in which a ring shuttle 916 of the delivery system900 has substantially pushed the annuloplasty ring 902 out of thedelivery catheter 914, but the plane of the annuloplasty ring 902 isstill aligned with (e.g., approximately parallel to) the longitudinalaxis of the delivery catheter 914. In FIG. 9C, the annuloplasty ring 902may be in a configuration, for example, immediately before a ringdeployment wire 923 cooperates with the pivot 108 to rotate theannuloplasty ring 902 (see FIG. 9D). In the configuration shown in FIG.9C, the distal end of the ring deployment wire 923 includes a bend orhook 932 as it passes through a hole in the pivot 108. The ringdeployment wire 923 includes a superelastic shape memory material (e.g.,Nitinol), and bending the distal end of the ring deployment wire 923into the hook 932 shape spring loads the annuloplasty ring 902 withinthe outer jacket delivery catheter 914 such that the annuloplasty ring902 automatically rotates about the pivot 108 upon exiting the outerjacket delivery catheter 914. At this third stage of deployment, thehook 932 shape formed in the superelastic ring deployment wire 923 isready to unload (return to a heat-set memorized straight configuration)as soon as the delivery catheter 914 no longer prevents it from doingso. The suture 919 may be utilized to draw together the male components952 and female components 954 of a ring closure lock 950.

FIG. 9D is a perspective view of the annuloplasty ring 902 in a fourthstage of deployment in which the plane of the annuloplasty ring 902 (inits annular operable geometry) has been changed to be perpendicular tothe longitudinal axis of the delivery catheter 914. As shown in FIG. 9D,the superelastic ring deployment wire 923 has returned to its heat set(memorized) straight configuration. At this fourth stage of deployment,the plane of the annuloplasty ring 902 is configured to be parallel tothe plane of the heart valve annulus. In situ within the heart, alongitudinal axis of the delivery catheter 914 is oriented parallel tothe direction of blood through the valve and approximately perpendicularto the plane of the heart valve. The annuloplasty ring 902, whenoriented such that the plane of the annuloplasty ring 902 is transverseto (and perpendicular or approximately perpendicular to) thelongitudinal axis of the delivery catheter 914, is oriented such thatthe plane of the annuloplasty ring 902 is parallel or approximatelyparallel to the plane of the heart valve.

In further stages of deployment, the annuloplasty ring 902 may beexpanded and/or pressed against the heart valve annulus before deployingthe anchors (such as the curved anchors 104 shown in FIGS. 1A and 1B).As discussed above, certain anchor embodiments propel themselves intothe tissue of the heart valve annulus upon being deployed. In otherembodiments, the anchors (such as the linear anchors 710 shown in FIG.7) may be deployed before pressing the annuloplasty ring 902 against theannulus. After the annuloplasty ring 902 is anchored to the heart valveannulus and transitioned to the contracted state, the ring deploymentwire 923 may be pulled from the hole in the pivot 108 to release theannuloplasty ring 902 from the ring shuttle 916. Any remaining sutures,such as the first suture 919, may also be cut and/or pulled from theannuloplasty ring 902 before the delivery catheter 914 is removed fromthe heart.

Example Expansion Tool Embodiments

FIG. 10 is a schematic diagram illustrating a perspective, partialcross-sectional view of a heart 1000 during the expansion of anadjustable annuloplasty ring 1002 using a balloon tool 1004 as anexpansion tool 1004, preparatory to affixation to the annulus of themitral valve 1006 according to one embodiment. As shown, a deliverycatheter 1010 extends from the left ventricle into the left atriumthrough the leaflets of the mitral valve 1006. Thus, this illustratedembodiment may correspond to, for example, a trans-apical approach or aretrograde approach, as discussed above. Artisans will recognize fromthe disclosure herein, however, that similar principles as thoseillustrated may be used for trans-septal approaches.

In FIG. 10, an expansion tool 1004 is being used to expand theannuloplasty ring 1002. The annuloplasty ring 1002 is positioned on ornext to the annulus of the mitral valve 1006. The expansion tool 1004 isdisposed within the annuloplasty ring 1002 (and within the mitral valve1006) to expand the annuloplasty ring 1002 to transition it from acontracted state to an expanded state. The expansion tool 1004 of theillustrated embodiment of FIG. 10 is a balloon expansion tool 1004. Theballoon expansion tool 1004 is inflated to expand the annuloplasty ring1002 to an expanded state. The balloon expansion tool 1004 shown in FIG.10 includes two sections and may be considered a “multi-chamber” balloonwith two chambers. In other embodiments, a balloon expansion tool 1004with a single chamber or a balloon with more than two chambers may beused.

In the embodiment shown in FIG. 10, the inflated balloon expansion tool1004 may reduce or prevent the flow of blood through the mitral valveduring at least part of the implantation procedure. In such embodiments,inflation of the balloon expansion tool 1004 may last 20 seconds or lessto prevent adverse consequences of occluding the mitral valve 1006. Inother embodiments, such as the embodiment of an expansion tool shown inFIGS. 11, 12A-12B, 13A-13B, and 14A-14B, blood is allowed to flowthrough the mitral valve 1006 during the entire procedure.

FIG. 11 is a schematic diagram illustrating a perspective, partialcross-sectional view of a heart 1100 during the expansion of anadjustable annuloplasty ring 1102 using a cage or basket tool 1104 as anexpansion tool 1104, preparatory to affixation to the annulus of themitral valve 1106 according to another embodiment.

The basket expansion tool 1104 may include a plurality of flexiblemembers 1108 that lay flat against a central rod 1114 during insertionof the basket expansion tool 1104 through the delivery catheter (seeFIG. 10) and may be forced into an expanded configuration (shown in FIG.11) when the central rod 1114 is pushed into an end cap 1112. In anotherembodiment, each of the plurality of flexible members 1108 may comprisea superelastic material so as to spring from a delivery catheter intothe expanded configuration shown in FIG. 11.

FIGS. 12A and 12B are schematic diagrams illustrating perspective viewsof an intimate contact tool 1200 that may be used as an expansion tool1200 of a percutaneous annuloplasty system according to one embodiment.FIG. 12A depicts a perspective view of the intimate contact tool 1200separated from other components of the percutaneous annuloplasty system.FIG. 12B depicts the intimate contact tool 1200 disposed through adelivery catheter 1252 and engaging an annuloplasty ring 1250.

In order to achieve good intimate contact between an annuloplasty ring1250 (shown in FIG. 12B) and the tissue of the target heart valve (e.g.,the annulus of the heart valve), the intimate contact tool 1200 may beused to position, orient, and otherwise manipulate the annuloplasty ring1250 in the annular operable geometry, prior to affixation to tissue ofthe valve. The intimate contact tool 1200 may be a metallic ribstructure having a plurality of arms 1202 a, 1202 b, 1202 c(collectively 1202) or prongs configured to extend outward at an anglefrom a central column 1204. The rib structure, and specifically the arms1202 and central column 1204, may be laser cut from a shape memorymaterial, such as Nitinol. The intimate contact tool 1200 may be cutfrom a hollow tube to give the central column 1204 a hollow cylindricalshape. The arms 1202 may then be heat set to extend at an angle from thecentral column 1204.

The illustrated intimate contact tool 1200 of FIGS. 12A and 12B mayinclude three arms 1202 arranged, for example, in the shape of a tripod.The plurality of arms 1202 of the intimate contact tool 1200 may beloaded into a delivery catheter 1252 together with the annuloplasty ring1250 (e.g., configured in the elongate insertion geometry). As the arms1202 emerge from a distal end of the delivery catheter 1252 they mayautomatically expand outward. The intimate contact tool 1200, andspecifically the plurality of arms 1202, may be configured to align withand engage the annuloplasty ring 1200 as shown in FIG. 12B. When alignedand engaged with the annuloplasty ring 1250, the intimate contact tool1200 can be used to push/pull the annuloplasty ring 1250 toward thetissue of an annulus of a heart valve.

The illustrated intimate contact tool of FIGS. 12A and 12B may beconfigured to engage a top surface of the annuloplasty ring 1250,through the annuloplasty ring 1250, to pull the annuloplasty ring 1250downward. For example, the plurality of arms 1202 may include a curved,angled, or hooked portion at a distal end to facilitate engagement withthe annuloplasty ring 1250. The intimate contact tool 1200 can be usedto pull the annuloplasty ring 1250 toward the heart valve to facilitateintimate contact of the annuloplasty ring 1250 with the annulus.Intimate contact, or close abutment, of the annuloplasty ring 1250 withthe annulus of the valve can enhance an anchor deployment process tofasten the annuloplasty ring 1250 to the annulus.

The intimate contact tool 1200, and specifically the arms 1202, may alsobe configured to function as an expansion tool to engage theannuloplasty ring 1250 and effectuate and/or facilitate transition ofthe annuloplasty ring 1250 from a contracted state to an expanded state.For example, a superelastic property and memorized shape of theplurality of arms 1202 may effectuate expansion of the annuloplasty ring1250. The superelastic arms 1202 may engage an inner surface of theannuloplasty ring 1250 and exert outward force to expand theannuloplasty ring 1250. In other embodiments, a suture or other elongatemember may enable percutaneous manipulation of one or more of theplurality of arms to effectuate expansion of the annuloplasty ring 1250.

FIGS. 13A and 13B are schematic diagrams illustrating perspective viewsof an intimate contact tool 1300 to be used as an expansion tool of apercutaneous annuloplasty system according to another embodiment. Theillustrated intimate contact tool 1300 includes only two arms 1302 a,1302 b (collectively 1302) or prongs. FIG. 13A depicts a perspectiveview of the intimate contact tool 1300 separated from other componentsof the percutaneous annuloplasty system. FIG. 13B depicts the intimatecontact tool 1300 disposed through a delivery catheter 1352 and engagingan annuloplasty ring 1350. The intimate contact tool 1300 may be used toposition, orient, and otherwise manipulate the annuloplasty ring 1350 toachieve intimate contact in abutment with tissue of the annulus of atarget heart valve.

The arms 1302 of the intimate contact tool 1300 are configured to extendoutward at an angle from a central column 1304, thereby forming a ribstructure. The rib structure, and specifically the arms 1302 and centralcolumn 1304, may be laser cut from a shape memory material, such asNitinol. The intimate contact tool 1300 may be cut from a hollow tube togive the central column 1304 a hollow cylindrical shape. The arms 1302may then be heat set to extend at an angle from the central column 1304.

The illustrated intimate contact tool 1300 of FIGS. 13A and 13B includestwo arms 1302 a, 1302 b arranged, for example, in the shape of a bipod.The two arms 1302 a, 1302 b in cooperation with a ring shuttle 1354 of adelivery system of the percutaneous annuloplasty system form a tripodstructure engaging the annuloplasty ring 1350 at three points. Theplurality of arms 1302 may be loaded into a delivery catheter 1352together with the annuloplasty ring 1350 (e.g., configured in theelongate insertion geometry). As the arms 1302 emerge from a distal endof the delivery catheter 1352 they may automatically expand outward andmay be configured to align with and engage the annuloplasty ring 1350 asshown in FIG. 13B. When aligned and engaged with the annuloplasty ring1350, the intimate contact tool 1300 can be used to push/pull theannuloplasty ring 1350 toward the tissue of the annulus of a heartvalve.

The illustrated intimate contact tool of FIGS. 13A and 13B may beconfigured to engage a top surface of the annuloplasty ring 1350 to pullthe annuloplasty ring 1350. For example, the plurality of arms 1302 mayinclude a curved, angled, or hooked portion at a distal end tofacilitate engagement with the annuloplasty ring 1350. The intimatecontact tool 1300 can be used to pull the annuloplasty ring 1350 towardthe heart valve to facilitate intimate contact of the annuloplasty ring1350 with the annulus to enhance an anchor deployment process to fastenthe annuloplasty ring 1350 to the annulus.

The intimate contact tool 1300, and specifically the arms 1302, may alsobe configured to function as an expansion tool to engage theannuloplasty ring 1350 and effectuate and/or facilitate transition ofthe annuloplasty ring 1350 from a contracted state to an expanded state.For example, a superelastic property and memorized shape of theplurality of arms 1302 may enable the arms 1302 to engage an innersurface of the annuloplasty ring 1350 and exert outward force to expandthe annuloplasty ring 1350. In other embodiments, a suture or otherelongate member may enable percutaneous manipulation of one or more ofthe plurality of arms 1302 to effectuate expansion of the annuloplastyring 1350.

FIGS. 14A and 14B are schematic diagrams illustrating perspective viewsof an expansion tool 1400 of a percutaneous annuloplasty systemaccording to another embodiment. The intimate contact tool 1400 may beconfigured to push or press an annuloplasty ring 1450 (from above) intointimate contact with, or abutment against, an annulus of a target heartvalve. The illustrated intimate contact tool 1400 includes two arms 1402a, 1402 b (collectively 1402) or prongs. FIG. 14A depicts a perspectiveview of the intimate contact tool 1400 separated from other componentsof the percutaneous annuloplasty system. FIG. 14B depicts the intimatecontact tool 1400 disposed through a delivery catheter 1452 and engagingan annuloplasty ring 1450 from above. The intimate contact tool 1400 maybe used to position, orient, and otherwise manipulate the annuloplastyring 1450 to achieve intimate contact with or abutment against tissue ofthe annulus of a target heart valve.

The arms 1402 of the intimate contact tool 1400 are configured to extendoutward at an angle from a central column 1404, thereby forming a ribstructure. The rib structure, and specifically the arms 1402 and centralcolumn 1404, may be laser cut from a shape memory material, such asNitinol. The intimate contact tool 1400 may be cut from a hollow tube togive the central column 1404 a hollow cylindrical shape. The arms 1402may then be heat set to extend at an angle from the central column 1404.

The illustrated intimate contact tool 1400 of FIGS. 14A and 14B includestwo arms 1402 a, 1402 b arranged, for example, in the shape of a bipod.The two arms 1402 a, 1402 b in cooperation with a ring shuttle 1454 ofthe percutaneous annuloplasty system form a tripod structure engagingthe annuloplasty ring 1450 at three points. The plurality of arms 1402may be loaded into a delivery catheter 1452 together with theannuloplasty ring 1450 (e.g., configured in the elongate insertiongeometry). As the arms 1402 emerge from a distal end of the deliverycatheter 1452 they may automatically expand outward and may beconfigured to align with and engage the annuloplasty ring 1450 as shownin FIG. 14B. When aligned and engaged with the annuloplasty ring 1450,the intimate contact tool 1400 can be used to push/pull the annuloplastyring 1450 toward the tissue of an annulus of a heart valve.

The illustrated intimate contact tool of FIGS. 14A and 14B may beconfigured to engage a top surface of the annuloplasty ring 1450 fromabove to push the annuloplasty ring 1450. For example, the plurality ofarms 1402 may include a curved, angled, or hooked portion at a distalend to facilitate engagement with the annuloplasty ring 1450. Theintimate contact tool 1400 can be used to push the annuloplasty ring1450 from above downward toward the heart valve to facilitate intimatecontact of the annuloplasty ring 1450 with the annulus to enhance ananchor deployment process to fasten the annuloplasty ring 1450 to theannulus.

The intimate contact tool 1400, and specifically the arms 1402, may alsobe configured to function as an expansion tool to engage theannuloplasty ring 1450 and effectuate and/or facilitate transition ofthe annuloplasty ring 1450 from a contracted state to an expanded state.For example, a superelastic property and memorized shape of theplurality of arms 1402 may enable the arms 1402 to engage an innersurface of the annuloplasty ring 1450 and exert outward force to expandthe annuloplasty ring 1450. The intimate contact tool 1400 may bemanipulated to sandwich the annuloplasty ring 1450 between the annulusof the target valve, or otherwise press the annuloplasty ring 1450against the valve, and thereby effectuate expansion of the annuloplastyring 1450 to the expanded state. In other embodiments, a suture or otherelongate member may enable percutaneous manipulation of one or more ofthe plurality of arms 1402 to effectuate expansion of the annuloplastyring 1450.

Example Ring Closure Lock Components

FIG. 15A is a schematic diagram illustrating a perspective view of anangled snap 1502 of a ring closure lock (see, e.g., the ring closurelock 106 of FIGS. 1A and 1B) according to one embodiment. FIG. 15B is aschematic diagram illustrating a top view of the angled snap 1502 ofFIG. 15A. The ring closure lock may include both the angled snap 1502having a male configuration and a receiving component (not shown, butsee FIGS. 16A and 16B) having a female configuration that is configuredto receive the male components 1506, 1508 of the angled snap 1502. Theangled snap 1502 may include a first male component 1506 and a secondmale component 1508 protruding from a base 1504.

The first male component 1506 may be configured to securely couple theangled snap 1502 to, for example, a distal end of an annuloplasty ring1550, as shown in FIG. 15C. The angled snap 1502 may be coupled to theannuloplasty ring 1550 by a pin (not shown) disposed transverselythrough a distal end of the annuloplasty ring 1550 and a hole 1512through the first male component 1506.

The second male component 1508 may comprise a bendable tab to enablecoupling to a proximal end (see, e.g., FIGS. 16A and 16B) of theannuloplasty ring 1550 from a variety of angles. The second malecomponent 1508 may have a first dimension that is relatively thin toallow the second male component 1508 to be bent in a direction of thatfirst dimension and may have a second dimension that is relatively thickto make the second male component 1508 rigid in a direction of thesecond dimension. A hole 1514 through the second male component 1508 mayreceive a snapping suture (see, e.g., suture 919 of FIGS. 9A-9C)configured to be pulled or otherwise percutaneously manipulated to drawand/or snap together the ends of the annuloplasty ring 1550 totransition the annuloplasty ring 1550 from the elongate insertiongeometry to the annular operable geometry. The second male component1508 may couple to the proximal end of the annuloplasty ring 1550 bybeing received into a receiving component of the ring closure lock, suchas the receiving component shown in FIGS. 16A and 16B and describedbelow with reference to the same.

The first male component 1506 and second male component 1508 may beangled relative to each other to facilitate coupling the ends of theannuloplasty ring 1550 at an apex of a curved posterior side of theannuloplasty ring 1550. The annular operable geometry of theannuloplasty ring 1550 may be a D-shape, and a relative angle θ of thefirst male component 1506 and second male component 1508 may facilitatecoupling the ends of the annuloplasty ring 1550 at the apex of theD-shape, such as in the example embodiment of FIGS. 1A and 1B. Describeddifferently, the base 1504 may define a longitudinal axis L and one orboth of the first male component 1506 and second male component 1508 maybe disposed at angles α₁, α₂, respectively, to the longitudinal axis L,as shown in FIG. 15B. The first male component 1506 and second malecomponent 1508, because they are disposed at an angle (angles α₁, α₂,respectively), may aid in coupling a proximal end and a distal end ofthe annuloplasty ring 1550 to transition the annuloplasty ring 1550 fromthe elongate insertion geometry to the annular operable geometry and mayfurther aid in defining a D-shape annular operable geometry of theannuloplasty ring 1550. In the illustrated embodiment, the angle α₁ andthe angle α₂ may be the same, or approximately the same. In otherembodiments, the angles α₁, α₂ may be different.

The base 1504 may include a distal ring interface surface 1520 and aproximal ring interface surface 1522 to abut or otherwise interface withthe distal end of the annuloplasty ring 1550 and the proximal end of theannuloplasty ring 1550, respectively. The first male component 1506 mayextend from the distal ring interface surface 1520, and the second malecomponent 1508 may extend from the proximal ring interface surface 1522.The distal ring interface surface 1520 and the proximal ring interfacesurface 1522 may be angled relative to each other to aid in defining aD-shape annular operable geometry of the annuloplasty ring 1550.

Although the illustrated embodiment of the angled snap 1502 may bedescribed herein with the first male component 1506 being configured toextend from the distal ring interface surface 1520 to securely couple tothe distal end of the annuloplasty ring 1550, skilled artisansappreciate that a mirror configuration is possible wherein the firstmale component 1506 extends from the proximal ring interface surface1522 to securely engage the proximal end of the annuloplasty ring 1550and correspondingly the second male component 1508 extends from thedistal ring interface surface 1520 to enable coupling to the distal endof the annuloplasty ring 1550. As noted above, the second male component1508 may comprise a bendable tab configured to be inserted into areceiving component of a ring closure lock.

FIGS. 16A and 16B are schematic diagrams illustrating perspectivecross-section views of a receiving component 1602 of a ring closure lock(see, e.g., ring closure lock 106 of FIGS. 1A and 1B) according to oneembodiment. FIG. 16C is a schematic diagram illustrating an end view ofthe receiving component 1602 of FIGS. 16A and 16B. Referring generallyand collectively to FIGS. 16A-16C, the illustrated receiving component1602 is coupled to a proximal end of an annuloplasty ring 1650. Skilledartisans appreciate that, in other embodiments, the receiving component1602 may be coupled to a distal end of the annuloplasty ring 1650. Thereceiving component 1602 may be configured to receive a male componentof a snap component of the ring closure lock. For example, the receivingcomponent 1602 may be configured to receive the second male component1508 of the angled snap 1502 of FIGS. 15A-15C.

The illustrated receiving component 1602 of FIGS. 16A-16C may include aconical cavity 1604 tapering to a slot 1606 sized and shaped to receivethe male component. The conical cavity 1604 allows a leading portion ofthe male component to smoothly enter the slot 1606 in the receivingcomponent 1602 even if the male component and the slot 1606 are notperfectly aligned when they meet. The slot 1606 may have appropriatedimensions to allow the male component, with a suture placed through it,to pass through without any interference. The suture can be used topercutaneously pull the male component through the slot 1606.

The receiving component 1602 may further include a snapping disk 1608that may be disposed at the slot 1606 at a side opposite or behind theconical cavity 1604, in abutment with or otherwise adjacent to theannuloplasty ring 1650. The snapping disk 1608 may allow a malecomponent to enter the slot 1606 from the conical cavity 1604, but mayrestrict or prevent the male component from exiting or being retractedback through the slot 1606. As illustrated, the snapping disk 1608 maycomprise a plurality of tabs configured to engage a male component. Inother embodiments, the receiving component may not include a snappingdisk 1608, but rather the tabs can be laser cut when the body member ofthe annuloplasty ring 1650 is cut and the tabs can be bent inside toperform a similar function as the snapping disk 1608.

Example Proximal End Handle

FIG. 17A is a schematic diagram illustrating a perspective view of aproximal end handle 1700 of a percutaneous annuloplasty system accordingto one embodiment. FIG. 17B is a schematic diagram illustrating aperspective cross-section view of the proximal end handle 1700 of FIG.17A. The proximal end handle 1700 may enable percutaneous transcatheterdeployment of an annuloplasty ring. More particularly, the proximal endhandle 1700 may enable percutaneous manipulation of an annuloplastysystem configured to deliver, configure, and orient an annuloplasty ringand to fasten the annuloplasty ring to the annulus of a target heartvalve.

The illustrated embodiment of a proximal end handle may comprise variousrotating knobs that perform or enable various functions. There may be arotatable knob for each function to be performed. A ring closure knob1702 may enable closure of the annuloplasty ring to transition from anelongate insertion geometry to an annular operable geometry. A ring snapknob 1704 may enable snapping together of first and second ends (e.g.,distal and proximal ends) of the annuloplasty ring or other manipulationof a ring closure lock. An anchor deployment knob 1706 may enabledeployment of anchors of an annuloplasty ring to fasten the annuloplastyring to the annulus of the target heart valve. An A-P adjustment knob1708 may enable contraction of the annuloplasty ring from an expandedstate to a contracted state. In other embodiments, the A-P adjustmentknob 1708 may also enable manipulation of an expansion tool tofacilitate expansion of the annuloplasty ring to an expanded state(e.g., prior to deployment of the anchors). A ring release knob 1710 mayenable release of the annuloplasty ring from a delivery system and/ordelivery shuttle of a percutaneous annuloplasty system. Additional orfewer knobs may be possible, as dependent on functions to be performed.

Each of the knobs 1702, 1704, 1706, 1708, 1710 may be coupled to andmanipulate an independent system of cables or sutures by rotating therespective knob 1702, 1704, 1706, 1708, 1710. As shown in FIG. 17B, eachof the knobs 1702, 1704, 1706, 1708, 1710 may be mechanically coupled toa translation gear mechanism. The gear mechanism may be connected to apulling cable or suture that is configured to perform a given function.

Example Methods for Percutaneous Annuloplasty

FIG. 18 is a flowchart of a method 1800 for repairing a defective heartvalve according to one embodiment. The method 1800 includespercutaneously introducing 1810 a distal end of a first catheter into aleft atrium of a heart and inserting 1812 a annuloplasty ring, attachedto a second catheter, through the first catheter into the left atrium.The annuloplasty ring may include a superelastic shape memory materialthat may aid to transition 1814 the annuloplasty ring from an elongateinsertion geometry to an annular operable geometry as the annuloplastyring exits the distal end of the first catheter. The method 1800 mayinclude pulling 1816 a first suture, connected to the annuloplasty ringthrough the second catheter, to draw together and couple the ends of theannuloplasty ring together, for example at a ring closure lock.

The method 1800 may further include automatically rotating 1818 theannuloplasty ring to change a plane of the annuloplasty ring from afirst orientation that is parallel to the second catheter to a secondorientation that is parallel to a plane of the mitral valve annulus. Apercutaneously, transcatheter-operated expansion tool may be actuated1820 to expand the annuloplasty ring in the annular operable geometry toan expanded state to thereby increase an A-P distance of theannuloplasty ring. Expansion of the annuloplasty ring may includeexpanding a biasing element of the annuloplasty ring.

The method 1800 may include positioning 1822 the annuloplasty ring inabutment or similar relatively intimate contact with an annulus of atarget valve of the heart to enhance a process of fastening theannuloplasty ring to the annulus of the target heart valve. The method1800 may include pulling a second suture, connected to the annuloplastyring through the second catheter, to deploy 1824 a plurality of tissueanchors from the annuloplasty ring. With the anchors deployed and theannuloplasty ring fastened to the tissue of the target heart valve, theexpansion tool may be released 1826. The annuloplasty ring may becontracted 1828 to transition the annuloplasty ring in the operablegeometry to a contracted state to decrease the A-P distance and therebydecrease the A-P distance of the target heart valve to improvecoaptation and reduce regurgitation through the target heart valve. Incertain embodiments, contraction 1828 of the annuloplasty ring may beaccomplished by biasing elements that have stored potential energyduring expansion of the annuloplasty ring.

The method 1800 may further include detaching 1830 the annuloplasty ringfrom the second catheter and the first and second sutures, and removethe first and second catheters from the heart.

Those having skill in the art will understand from the disclosure hereinthat many changes may be made to the details of the above-describedembodiments without departing from the underlying principles of theinvention. The scope of the present invention should, therefore, bedetermined only by the following claims.

What is claimed is:
 1. An adjustable annuloplasty ring for percutaneous,transcatheter heart valve repair, the annuloplasty ring comprising: abody member that is transitionable from an elongate insertion geometryto an annular operable geometry, the elongate insertion geometry toallow percutaneous passage of the annuloplasty ring, via a catheter,into a heart of a patient, and the annular operable geometry having anexpanded state to conform to an annulus of a target valve of the heartand a contracted state to reduce a diameter of the annulus of the targetvalve; a plurality of anchors percutaneously deployable from the bodymember in the annular operable geometry to engage the annulus of thetarget valve; a biasing element disposed between a first region and asecond region of the body member, the biasing element configured to beexpanded to increase an anterior-posterior distance of the annuloplastyring in the annular operable geometry to the expanded state in abutmentwith the annulus of the target valve, such that subsequent deployment ofthe plurality of anchors fastens the body member to the annulus of thetarget valve, wherein the biasing element biases the annuloplasty ringin the operable geometry toward the contracted state such that expansionof the annuloplasty ring to the expanded state stores potential energyin the biasing element and releasing the biasing element releases thepotential energy to force movement of the first region of the bodymember toward the second region of the body member to decrease theanterior-posterior distance of the annuloplasty ring to the contractedstate and thereby decrease an anterior-posterior distance of the targetvalve to improve leaflet coaptation of the target valve and reduceregurgitation through the target valve.
 2. The adjustable annuloplastyring of claim 1, wherein the target valve is a mitral valve.
 3. Theadjustable annuloplasty ring of claim 2, wherein the percutaneouspassage, via a catheter, into the heart of the patient comprises anendovascular delivery into the heart of the patient.
 4. The adjustableannuloplasty ring of claim 3, wherein the endovascular delivery into theheart comprises a trans-septal approach.
 5. The adjustable annuloplastyring of claim 3, wherein the endovascular delivery into the heartcomprises a retrograde approach.
 6. The adjustable annuloplasty ring ofclaim 2, wherein the percutaneous passage, via a catheter, into theheart of the patient comprises a trans-apical approach.
 7. Theadjustable annuloplasty ring of claim 1, wherein the biasing elementcomprises an integral biasing portion of the body member.
 8. Theadjustable annuloplasty ring of claim 7, wherein the integral biasingportion of the body member comprises a spiral cut in a portion of thebody member to form a spiral shape in the body member that is expandableto the expanded state and that is biased toward the contracted state. 9.The adjustable annuloplasty ring of claim 1, wherein the biasing elementcomprises a spring and the first and second regions of the body membercomprises first and second segments, the biasing element disposedbetween the first and second segments and configured to be disposed in arelaxed state when the annuloplasty ring is in the contracted state andconfigured to be disposed in an extended strained state when theannuloplasty ring is in the expanded state.
 10. The adjustableannuloplasty ring of claim 9, wherein the biasing element forcesmovement of the first segment in a telescopic manner into the secondsegment.
 11. The adjustable annuloplasty ring of claim 1, whereinmovement of the first region of the body toward the second region of thebody decreases the anterior-posterior distance of the annuloplasty ringbetween 3 mm and 5 mm.
 12. The adjustable annuloplasty ring of claim 1,wherein the annular operable geometry forms a D-shaped ring.
 13. Theadjustable annuloplasty ring of claim 1, further comprising a secondbiasing element disposed between a third region of the body member andthe second region of the body member, the second biasing elementconfigured to be expanded to increase an anterior-posterior distance ofthe annuloplasty ring in the annular operable geometry to the expandedstate in abutment with the annulus of the target valve, wherein thesecond biasing element biases the annuloplasty ring in the operablegeometry toward the contracted state such that expansion of theannuloplasty ring to the expanded state stores potential energy in thesecond biasing element and releasing the second biasing element releasesthe potential energy to force movement of the third region of the bodymember toward the second region of the body member to decrease theanterior-posterior distance of the annuloplasty ring to the contractedstate.
 14. The adjustable annuloplasty ring of claim 1, wherein thebiasing element is configured to be actuated percutaneously by anelongate mechanical coupling extending from the biasing element, throughthe catheter, to a position external to a body of the patient.
 15. Theadjustable annuloplasty ring of claim 14, wherein the elongatemechanical coupling comprises a suture.
 16. The adjustable annuloplastyring of claim 14, wherein the mechanical coupling comprises a cable. 17.The adjustable annuloplasty ring of claim 1, wherein actuation of thebiasing element comprises releasing the biasing element.
 18. Theadjustable annuloplasty ring of claim 1, the body member forming anouter hollow member, wherein adjacent regions of the body membercooperate with one another to change the outer hollow member from theelongate insertion geometry to the annular operable geometry, theadjustable annuloplasty ring further comprising; an internal anchormember located at least partially within the outer hollow member, theinternal anchor member comprising the plurality of anchors, and theinternal anchor member configured to move the plurality of anchors withrespect to a plurality of windows in the outer hollow member toselectively deploy the plurality of anchors through correspondingwindows. 19.-30. (canceled)